Characteristics of COVID-19 Infection Among PREGnant Women (CCOVID-PREG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04398264|
Recruitment Status : Completed
First Posted : May 21, 2020
Last Update Posted : April 7, 2022
In December 2019, Coronavirus infection (COVID-19) was identified as causing serious respiratory infection in humans. Initially COVID-19 was propagated by infected symptomatic individuals; currently the disease is disseminated by asymptomatic COVID-19 positive subjects. The prevalence of asymptomatic COVID-19 individuals is unknown.
Due its physiologic immune suppression, pregnancy is a vulnerable time for severe respiratory infections including COVID-19.
Limited information is available regarding the impact of COVID-19 in pregnancy and the prevalence and demographic profile of asymptomatic pregnant women.
Despite reports of 15-20% positive COVID-19 tests in women admitted to Labor and Delivery, professional obstetric medical societies still recommend not prioritizing testing of patients who are asymptomatic.
In the USA, COVID-19 symptomatic patients come predominantly from lower income, Black and Latino communities. No data are available on the rate and demographic distribution of asymptomatic positive COVID-19 pregnant women.
To minimize the risk of inadvertent exposure asymptomatic individuals, recently our institution started COVID-19 testing in all admitted pregnant women. The investigators expect to gain knowledge on the impact of COVID-19 in pregnant women especially if asymptomatic and compare to other respiratory infections.
|Condition or disease||Intervention/treatment|
|Corona Virus Infection Pregnancy Related||Other: COVID-19 positive via testing|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||650 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Characteristics of COVID-19 Infection Among PREGnant Women|
|Actual Study Start Date :||July 22, 2020|
|Actual Primary Completion Date :||March 31, 2021|
|Actual Study Completion Date :||March 31, 2021|
- Other: COVID-19 positive via testing
Pregnant women admitted to Obstetric Units undergo RT-PCR testing for the detection of SARS-Cov2 (COVID-19 infection)
- Asymptomatic COVID-19 positive pregnant women [ Time Frame: Through completion of the study, an average of 1 year ]Rate of asymptomatic pregnant women who test positive for COVID-19 at the time of hospital admission
- Asymptomatic Hispanic COVID-19 positive pregnant women [ Time Frame: Through completion of the study, an average of 1 year ]Rate of Hispanic pregnant women among those asymptomatic COVID-19 positive on admission
- Follow up of asymptomatic COVID-19 positive pregnant women [ Time Frame: Through completion of the study, an average of 1 year ]Rate of asymptomatic positive pregnant women who later will develop COVID-19 related symptoms
- COVID-19 positive newborns [ Time Frame: Through completion of the study, an average of 1 year ]Prevalence of COVID-19 positive newborns from infected mothers
- Severe COVID-19 disease in pregnant women [ Time Frame: Through completion of the study, an average of 1 year ]Rate of COVID-19 positive pregnant women who develop respiratory / multi-organ complications requiring admission to Medicine or Intensive Care units / maternal death related to COVID-19
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04398264
|United States, Virginia|
|INOVA Health System|
|Falls Church, Virginia, United States, 22042|